Test Id : HBAGP
Hepatitis B Virus Surface Antigen Prenatal, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Diagnosis of acute, recent, or chronic hepatitis B
Determination of chronic hepatitis B status
Screening pregnant women for evidence of chronic hepatitis B (or hepatitis B carrier state) to identify neonates who are at high risk of acquiring hepatitis B at birth
This test should not be used as a screening or confirmatory test for blood donor specimens.
This test is not useful for diagnosis of hepatitis B during the "window period" of acute HBV infection (ie, after disappearance of hepatitis B surface antigen and prior to appearance of hepatitis B surface antibody).
Highlights
This test should be used to test or screen for chronic hepatitis B in pregnant individuals.
Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBNTP | HBs Ag Confirmation Prenatal, S | No | No |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If the hepatitis B virus surface antigen (HBsAg) result is reactive with cutoff index value greater than 1.00, then HBsAg confirmation testing will be performed at an additional charge.
Method Name
A short description of the method used to perform the test
Electrochemiluminescence Immunoassay (ECLIA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Hepatitis Bs Ag Prenatal
HBsAg (Hepatitis Bs Antigen) Prenatal
HBV Surface Antigen Prenatal
Hep B Surface Antigen Prenatal
Hepatitis Bs Ag Prenatal
HBAGP
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If the hepatitis B virus surface antigen (HBsAg) result is reactive with cutoff index value greater than 1.00, then HBsAg confirmation testing will be performed at an additional charge.
Specimen Type
Describes the specimen type validated for testing
Serum SST
Ordering Guidance
This test should not be used to test symptomatic individuals who may or may not have risk factors for hepatitis B virus (HBV) infection. For testing such individuals, order HBAG / Hepatitis B Virus Surface Antigen, Serum.
This test should not be used to screen or test asymptomatic, nonpregnant individuals with or without risk factors for HBV infection. For testing such patients, order HBGSN / Hepatitis B Virus Surface Antigen Screen, Serum.
This test is not intended for testing cadaver or grossly hemolyzed specimens. For testing such patients, order HBGCD / Hepatitis B Surface Antigen for Cadaveric or Hemolyzed Specimens, Serum, which is US Food and Drug Administration-approved for testing on these sources.
Additional Testing Requirements
Testing for acute hepatitis B virus (HBV) infection should also include HBIM / Hepatitis B Virus Core IgM Antibody, Serum, as during the acute HBV infection "window period," hepatitis B virus surface (HBs) antigen and HBs antibody may not be detected.
Necessary Information
1. Date of collection is required.
2. Indicate if specimens are from autopsy/cadaver or hemolyzed sources so that the proper US Food and Drug Administration-licensed assay can be performed.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.9 mL
Collection Instructions:
1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into a plastic vial.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Forms
If not ordering electronically, complete, print, and send 1 of the following with the specimen:
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
0.7 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 90 days | |
| Ambient | 72 hours | ||
| Refrigerated | 6 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Diagnosis of acute, recent, or chronic hepatitis B
Determination of chronic hepatitis B status
Screening pregnant women for evidence of chronic hepatitis B (or hepatitis B carrier state) to identify neonates who are at high risk of acquiring hepatitis B at birth
This test should not be used as a screening or confirmatory test for blood donor specimens.
This test is not useful for diagnosis of hepatitis B during the "window period" of acute HBV infection (ie, after disappearance of hepatitis B surface antigen and prior to appearance of hepatitis B surface antibody).
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If the hepatitis B virus surface antigen (HBsAg) result is reactive with cutoff index value greater than 1.00, then HBsAg confirmation testing will be performed at an additional charge.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles among injection drug users). The virus is found in various human body fluids, and it is known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted transplacentally.
Infection of the infant can occur if the mother is a chronic hepatitis B surface antigen carrier or has an acute HBV infection at the time of delivery. Transmission is rare if an acute infection occurs in either the first or second trimester of pregnancy.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Negative
Interpretation
Provides information to assist in interpretation of the test results
A reactive screen result (cutoff index value >1.00) confirmed as positive by hepatitis B surface antigen (HBsAg) confirmatory test is indicative of acute or chronic hepatitis B or chronic hepatitis B virus (HBV) carrier state.
Specimens with initially reactive test results but negative (not confirmed) by HBsAg confirmatory testing are likely to contain cross-reactive antibodies from other infectious or immunologic disorders. These unconfirmed HBsAg-reactive screening test results should be interpreted in conjunction with test results of other HBV serologic markers (eg, HBs antibody; hepatitis B core [HBc] total antibody, and HBc IgM antibody). If clinically indicated, repeat testing at a later date is recommended.
Confirmed presence of HBsAg is frequently associated with HBV replication and infectivity, especially when accompanied by the presence of HBe antigen or detectable HBV DNA.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This assay has not been licensed by the US Food and Drug Administration for the screening of blood, plasma, and tissue donors.
For diagnostic purposes, results should always be assessed in conjunction with the patient’s medical history, clinical examination, and other findings.
Individuals, especially neonates and children, who recently received hepatitis B vaccination may have transient positive hepatitis B virus surface antigen (HBsAg) test results because of the large dose of HBsAg used in the vaccine relative to the individual's body mass. In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur, causing false-positive results.
Positive HBsAg results will need to be reported by the healthcare professionals to their communicable disease surveillance units of state departments of health, as required by law in various states.
Current methods for the detection of HBsAg may not detect all infected individuals.
A negative test result does not exclude with certainty a possible exposure to or on infection with the hepatitis B virus. Negative test results obtained for persons with a past exposure may be caused by an antigen concentration below the detection limit of this assay or the lack of reactivity of the antigens to the antibodies used in this assay.
Performance characteristics of the Elecsys HBsAg II assay have not been established for testing of newborns or when used in conjunction with other manufacturers’ assays for specific hepatitis B virus serological markers.
Assay performance characteristics have not been established for the following specimen characteristics or specimen types:
-Grossly icteric (total bilirubin level of >40 mg/dL)
-Grossly lipemic (intralipid level of >2200 mg/dL)
-Grossly hemolyzed (hemoglobin level of >2200 mg/dL)
-Containing particulate matter
-Cadaveric specimens
-Specimen types other than serum
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. LeFevre ML; U.S. Preventive Services Task Force. Screening for hepatitis B virus infection in nonpregnant adolescents and adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(1):58-66. doi:10.7326/M14-1018
2. Jackson K, Locarnini S, Gish R. Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018;12(1):5-11. doi:10.1002/cld.729
3. Coffin CS, Zhou K, Terrault NA. New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019;156(2):355-368. doi:10.1053/j.gastro.2018.11.037
4. WHO guidelines on hepatitis B and C testing. Geneva: World Health Organization; February 2017. Accessed December 21, 2023. Available at www.who.int/publications/i/item/9789241549981
5. Centers for Disease Control and Prevention: Testing and public health management of persons with chronic hepatitis B virus infection. CDC; Updated March 28, 2022. Accessed December 21, 2023. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm
6. Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations - United States, 2023. MMWR Recomm Rep. 2023;72(1):1-25. doi:10.15585/mmwr.rr7201a1
Method Description
Describes how the test is performed and provides a method-specific reference
Hepatitis B Surface Antigen Screen:
The Elecsys HBsAg (hepatitis B surface antigen) II assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HBsAg present in the patient's sample reacts with 2 biotinylated monoclonal anti-HBs and a mixture of monoclonal anti-HBs and polyclonal anti-HBs labeled with a ruthenium complex react to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase), the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. The test result is determined by comparing the electrochemiluminescence signal generated from the reaction product in the patient's sample to the cutoff index (COI) value set from reagent lot-specific assay calibration.(Package insert: Elecsys HBsAG II. Roche Diagnostics; v3.0, 02/2022)
HBsAg Confirmation:
The Elecsys HBsAg (hepatitis B virus surface antigen) II Auto Confirm assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. This test is based on 2 parallel measurements. Patient's sample is treated first with the control pretreatment reagent (PT2) prior to immunoreaction. This measurement serves as a reference. For the second measurement, the sample is treated with the confirmatory pretreatment reagent (PT1) prior to immunoreaction. During incubation with confirmatory pretreatment, unlabeled polyclonal anti-HBs are bound to the sample HBsAg and thereby block the binding sites for the labeled antibodies used in the following immunoreaction. The confirmation result (%) is automatically assessed by determining the ratio of both measurements.
During testing, the auto-diluted sample is incubated with control pretreatment and confirmatory pretreatment, followed by formation of sandwich complexes of biotinylated monoclonal anti-HBs and a mixture of monoclonal anti-HBs and polyclonal anti-HBs labeled with a ruthenium complex. After addition of streptavidin-coated microparticles (solid phase), the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. The result is determined by comparing the electrochemiluminescence signal generated from the reaction product in the patient's samples to the cutoff index (COI) value set from reagent lot-specific assay calibration. The confirmation result (%) is calculated from the ratio of the COI obtained for the measurement with confirmatory pretreatment to the COI obtained for the measurement of control pretreatment reaction.(Package insert: Elecsys HBsAg II Auto Confirm. Roche Diagnostics; v1.0, 12/2020)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Sunday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
87340
87341 (if appropriate)
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| HBAGP | HBs Antigen Prenatal, S | 5196-1 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| HBSAP | HBs Antigen Prenatal, S | 5196-1 |